Bausch & Lomb ZyLET "approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Bausch & Lomb continues to expect a second-half 2004 approval of ZyLET (loteprednol etabonate 0.5%/tobramycin 0.3%) following a July "approvable" letter. The ophthalmic combination product "is aimed at treating patients with steroid-responsive inflammatory ocular conditions who have or are at risk of developing superficial bacterial ocular infections," former marketing partner Pharmos said. The ZyLET NDA was submitted in September 2003...
You may also be interested in...
Stalemate Over Virtual Audits In EU As Commission Tells TEAM-NB To Back Off
Notified bodies’ efforts to enhance a harmonized approach to remote audits have failed, raising questions about whether there is any avenue left to get vital devices certified by the 26 May EU MDR deadline.
Amneal’s Generics Business Reinvigorated By New Launches
As Amneal’s generics segment sees significant growth, the company has revealed plans to launch new products and expand in new markets. “We are extremely proud of the progress our company has made since we re-joined as leaders of Amneal,” said Chirag and Chintu Patel, co-CEOs of Amneal.
Medtech SMEs See Opportunities In UK Budget Of Few Surprises
Schemes and funding to support growth in the life sciences and medtech sectors featured in the UK government’s spring budget on 3 March.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: